Study of Cadonilimab (AK104) Plus Eribulin vs. Eribulin Monotherapy for Recurrent or Metastatic Triple-negative Breast Cancer

NCT06202313 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: AK104-IIT-007
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the efficacy and safety of Cadonilimab (AK104) plus Eribulin compared to the efficacy and safety of Eribulin monotherapy in the treatment of adult patients with recurrent, or metastatic triple negative breast cancer. The primary study hypothes is that the combination of Cadonilimab (AK104) plus Eribulin is superior to Eribulin monotherapy with respect to Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) as assessed by the Investigator.

Conditions

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Investigator

  PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD is defined as ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions was also considered PD. The PFS per RECIST 1.1 as assessed by Investigator will be presented.

  Up to approximately 1 year

Secondary Outcomes (6)

• Overall Survival (OS)

  Up to approximately 2 years

• Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by Investigator

  Up to approximately 1 year

• Duration of Response (DOR) Per RECIST 1.1 as Assessed by Investigator

  Up to approximately 1 year

• Number of Participants Who Experience an Adverse Event (AE)

  From randomization through 30 days after last dose of study treatment

• Number of Participants Who Experience a Serious AE (SAE)

  From randomization through 90 days after last dose of study treatment

Study Arms (2)

Cadonilimab + Eribulin

EXPERIMENTAL

Participants receive Cadonilimab 10mg/kg IV on Day 1 of each 21-day cycle PLUS Eribulin 1.4mg/m\^2 IV on Days 1 and 8 of each 21-day cycle.

Biological: Cadonilimab; Drug: Eribulin

Eribulin

ACTIVE COMPARATOR

Participants receive Eribulin 1.4mg/m\^2 IV on Days 1 and 8 of each 21-day cycle.

Drug: Eribulin

Interventions

Cadonilimab BIOLOGICAL

Participants receive Cadonilimab 10mg/kg IV on Day 1 of each 21-day cycle PLUS Eribulin 1.4mg/m\^2 IV on Days 1 and 8 of each 21-day cycle.

Also known as: AK104

Cadonilimab + Eribulin

Eribulin DRUG

Participants receive Eribulin 1.4mg/m\^2 IV on Days 1 and 8 of each 21-day cycle.

Cadonilimab + Eribulin; Eribulin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand and voluntarily sign a written informed consent form, which must be signed before the designated research procedures required for the study are carried out.
• Age at the time of signing the Informed Consent Form (ICF) is ≥ 18 years old and ≤ 75 years old, both male and female.
• The Eastern Cancer Collaborative Organization (ECOG) has a physical fitness score of 0 or 1.
• The expected survival period is ≥ 3 months.
• Recurrent or metastatic incurable triple negative breast cancer confirmed by histology and/or cytology.
• Having received ≤ 2-line systematic treatment for recurrent or metastatic diseases, including: ① untreated after recurrence or metastasis, but receiving paclitaxel and anthracycline drugs within 12 months before recurrence or metastasis (including neoadjuvant treatment stage and adjuvant treatment stage), Or ② After recurrence or metastasis, the subject has received 1-2 lines of treatment (including at least one anthracycline and one paclitaxel in the previous adjuvant treatment stage, neoadjuvant treatment stage, or treatment after recurrence/metastasis).
• According to the RECIST v1.1 standard, there is at least one measurable tumor lesion. Agree to provide archived or freshly obtained tumor tissue samples (formalin fixed paraffin embedded \[FFPE\] tissue wax blocks or at least 5 unstained tumor tissue slice samples) to confirm PD-L1 expression.
• The time interval between the last treatment: (a) If the last treatment is targeted therapy such as Olaparib, the interval should be ≥ 2 weeks; (b) If the last treatment is chemotherapy, an interval of ≥ 4 weeks is required.
• Having good organ function:
• Blood routine examination (no blood components or cell growth factors were used to support treatment within the first 2 weeks of randomization):
• Absolute neutrophil count (ANC) ≥ 1.5 × 10\^9/L;
• · Platelet count ≥ 100 × 10\^9/L; Hemoglobin ≥ 9.0g/dL.
• Kidney:
• Creatinine \< 1.5 × ULN, or creatinine clearance rate \* (CrCl) calculated value ≥ 50mL/min;
• \*The Cockcroft Fault formula will be used to calculate CrCl: CrCL (mL/min)={(140 age) × Body weight (kg) × F} /(SCr (mg/dL) × 72) Among them: F=1 for males and F=0.85 for females; SCr=serum creatinine. Urinary protein\<2+or 24-hour urine protein quantification\<1.0g.

You may not qualify if:

• human epidermal growth factor receptor 2 (HER2) is positive and/or hormone receptor is positive.
• Previously received treatment with PD-1 monoclonal antibody, PD-L1 monoclonal antibody, or CTLA-4 monoclonal antibody.
• Received systematic anti-tumor therapy within the first 4 weeks of randomization, including chemotherapy, radiation therapy, immunotherapy, targeted therapy (small molecule targeted therapy within the first 2 weeks of randomization), biological agent therapy, etc; Palliative local treatment within the first 2 weeks of randomization; Received systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) within the first 2 weeks of randomization; In the first 2 weeks of randomization, they received Chinese herbal medicine or traditional Chinese patent medicines and simple preparations with anti-tumor indications.
• Currently participating in another clinical study, unless it is an observational, non-interventional clinical study, or a follow-up period of an intervention study.
• Have active or untreated brain metastases, meningeal metastases, spinal cord compression, or leptomeningeal diseases. However, participants who meet the following requirements and have measurable lesions outside the central nervous system are allowed to be enrolled: asymptomatic after treatment, imageologically stable for at least 4 weeks before the start of study treatment (if there are no new or expanded brain metastases), and have stopped systemic glucocorticoid and anticonvulsant drug treatment for at least 2 weeks.
• Have clinical symptoms of pleural effusion, pericardial effusion, or pleural/ascites that require frequent drainage (≥ once per month).
• Active autoimmune diseases that require systematic treatment within the first 2 years of randomization, or autoimmune diseases that the researcher determines may recur or plan treatment. Except for the following:
• Skin diseases that do not require systematic treatment (such as vitiligo, alopecia, psoriasis, or eczema);
• Hypothyroidism caused by autoimmune thyroiditis requires only stable doses of hormone replacement therapy;
• Type I diabetes requiring only a stable dose of insulin replacement therapy;
• Childhood asthma has completely relieved, and no intervention is required in adulthood;
• Researchers have determined that the disease will not recur without external triggering factors.
• Any of the following cardiovascular or cerebrovascular diseases or risk factors:
• Myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack, acute or persistent myocardial ischemia, symptomatic heart failure (grade 2 or above according to the New York Heart Association functional classification), symptomatic or poorly controlled arrhythmia, or any arterial thromboembolism event occurred within the first 6 months of randomization.
• A history of deep vein thrombosis, pulmonary embolism, or other severe thromboembolism within the first 3 months of randomization.

Sponsors & Collaborators

• Shengjing Hospital: lead

Study Sites (1)

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110004, China

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

eribulin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Nan Niu

CONTACT

+8618940256668; niunannancy@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postdoctoral, Chief Physician

Study Record Dates

• First Submitted: January 1, 2024
• First Posted: January 11, 2024
• Study Start: February 10, 2024
• Primary Completion: December 30, 2025
• Study Completion (Estimated): December 30, 2028
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)